ICH guidelines: safety
HumanRegulatory and procedural guidanceResearch and developmentScientific guidelines
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The European Medicines Agency publishes scientific guidelines on human medicines that are harmonised by the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
For a complete list of scientific guidelines currently open for consultation, see Public consultations.
Nonclinical safety in paediatric medicines
Carcinogenicity studies
- ICH S1 Regulatory notice on changes to core guideline on rodent carcinogenicity testing of pharmaceuticals
- ICH S1A Need for carcinogenicity studies of pharmaceuticals
- ICH S1B Carcinogenicity: testing for carcinogenicity of pharmaceuticals
- ICH S1C (R2) Dose selection for carcinogenicity studies of pharmaceuticals